Regulatory Quality Systems Specialist – GMP & Compliance

Msd Ireland; Carlow; Hybrid; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

MSD Ireland in Carlow seeks a Quality Systems and Compliance – Regulatory Compliance Specialist to support CGMP/GDP for vaccine and biologics manufacturing. You will ensure data integrity and collaborate to promote a compliant culture on site, handling regulatory requests and dossier preparation.

The role requires a science degree and 5+ years in regulatory affairs or QA within GMP pharma, with experience in licensing, CMC submissions, and regulatory audits.

Qualifications

• Bachelor’s degree or higher in a related science discipline.
• 5+ years' experience in Regulatory Affairs, Quality Assurance, and/or Regulatory Compliance within a GMP-regulated pharmaceutical or biologics manufacturing environment.
• Demonstrated track record in CMC regulatory submissions, dossier preparation and management of health authority Q&A cycles.
• Hands-on experience supporting technology transfer and new product introduction at a site level.
• Experience managing licensing activities: Site Master File updates, MIA/IMP license maintenance, HPRA notifications, and market submissions.
• Experience with regulatory tracking systems and knowledge management to improve team performance and continuity.

Responsibilities

• Comply with CGMP/GDP in day-to-day activities.
• Maintain ALCOA data integrity for records and data.
• Prepare GMP dossiers to support new submissions and renewals.
• Manage regulatory requests and the site master file.
• Coordinate regulatory tracking and knowledge-management systems across functions.
• Participate in internal and external audits and inspections.
• Support regulatory compliance metrics and reporting.

Skills

CMC regulatory submissions

Regulatory tracking

GMP compliance

Documentation management

HPRA notifications

Regulatory audits

Quality systems

Cross-functional collaboration

Data integrity (ALCOA)

Education

Bachelor’s degree or higher in a related science

Job description

MSD Ireland in Carlow seeks a Quality Systems and Compliance – Regulatory Compliance Specialist to support CGMP/GDP for vaccine and biologics manufacturing. You will ensure data integrity and collaborate to promote a compliant culture on site, handling regulatory requests and dossier preparation.

The role requires a science degree and 5+ years in regulatory affairs or QA within GMP pharma, with experience in licensing, CMC submissions, and regulatory audits.